On Wednesday, the US Food and Drug Administration (FDA) unveiled its plan to modernize and speed up the agency’s work by advancing “regulatory science” to ensure that new products, drugs and medical devices are effective and don’t harm people, and that food is safe to eat.
The federal agency proposes to do this by developing new tools, standards and approaches, including working more closely with partners and establishing “centers of excellence” for research at universities, private companies and other government agencies.
In a 20-page white paper titled “Advancing Regulatory Science for Public Health”, the agency said there is “no single discovery – no magic bullet”, that will help the US tackle the unique regulatory challenges of the 21st century, and the only way to meet them is to have a range of new tools, approaches and ways of working with other scientists and developers.
Some of the projects set out in the paper include new approaches to testing drugs, looking for bacteria in food, and finding new antibiotics.
In a luncheon meeting timed to coincide with the release of the white paper, FDA Commissioner Margaret Hamburg told an audience at the National Press Club that regulatory science has been “under appreciated and under funded,” and that the funding will increase in this year’s budget.
Hamburg, who is a former health commissioner for New York City, described regulatory science as the bridge between science and the consumer, and it was “not as robust as it needs to be”. She said there was too big a gap between scientific advances and patient care and regulatory science can bridge that gap.
The gap is also a financial one: the billions of dollars spent on medical research needs to be translated into treatment, said Hamburg.
She said she hoped people would see the report as showing how regulatory science “really matters” and that the “time to act is now”.
The FDA defines regulatory science as the “science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products”.
The FDA regulates between 20 and 25 per cent of the value of products that consumers buy, from medicine, to food to toothpaste.
One area that could be improved is labelling of drugs in line with individual patient needs. As an example Hamburg said research could improve the labelling of coagulants so they explain the optimal dose according to patient age, diet, current medication and genetics.
Another area would be to develop genetic tests that help doctors decide the optimal dose. And she also described a project where FDA and National Institutes of Health scientists are working on an artificial pancreas for helping type 1 diabetes patients.
There is also a need to bring more outside talent into the FDA, and to tempt scientists to join the agency it will have to offer them interesting work and an attractive career ladder. To this end the agency has already developed a fellowship scheme.
An independent panel of advisers said in 2007 that the FDA was in danger of failing in its duty because it lacked scientific expertise.
Hamburg also said the FDA will be increasing its focus on the problem of antibiotic resistance which has grown as a result of decades of widespread use among humans and animals reared for food.
Antibiotics have been used to treat common colds and minor infections, and because they are often added to animal feed, for example to control infection in intensively farmed chickens and livestock, they have crept into the human food chain via meat, eggs, milk and cheese, and other animal products that people consume.
The result is that we now have a new generation of bacteria and life-threatening diseases that are highly resistant to even the newer antibiotics.
Hamburg said there was a need to be more judicious about how we use antibiotics as “we no longer have effective ways to treat serious infectious diseases”. She said she was concerned about the “distressingly low” level of research and development into new drugs, and particularly new antibiotics.
The cost of implementing the plan set out in the white paper will be met by $25 million of the proposed new FDA budget that the Obama administration has set before Congress for the fiscal year 2011 that started 1 October.
However, it is not clear whether the agency will be able to fulfil its wishes: the president has asked for the FDA budget to be increased by 23 per cent to a total of $4 billion, but Congress has yet to pass it.
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FDA, 6 October 2010.
Sources: FDA, National Press Club, Reuters, Associated Press, Wall Street Journal, Medpage Today, Bloomberg Businessweek (AP).
Written by: Catharine Paddock, PhD